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FDA Urged to Rule on Controversial Hand Soap Ingredients

September 17, 2024

new letter from the Green Science Policy Institute and Earthjustice, co-signed by more than 40 environmental and health organizations, urges the Food and Drug Administration to finalize its decision on whether it will continue allowing the use of three antimicrobial chemicals in over-the-counter hand and body washes. The agency was due to make its decision eight years ago but deferred at the request of manufacturers and their trade association. During this delay, evidence has grown on the health harms—but not the effectiveness—of these chemicals.

The antimicrobials in question are two quaternary ammonium compounds (QACs) called benzalkonium chloride and benzethonium chloride and an organohalogen called chloroxylenol. QACs have been linked to reproductive, respiratory, skin, and neurological harms and may contribute to the global health threat of antimicrobial resistance. All well-studied organohalogens have been found to be harmful to people, ecosystems, and especially to children.

In addition to posing health risks, these and other antimicrobials have not been shown to provide any benefit over plain soap for handwashing. In fact, the CDC instructs the public to only use plain soap and water to wash hands, noting that “studies have not found any added health benefit from using antibacterial soap.”

“Adding these antimicrobials to soaps isn’t doing anything to protect us from flu or COVID,” said Arlene Blum, Executive Director of the Green Science Policy Institute. “Instead, the chemicals can contribute to antimicrobial resistance, asthma, reproductive, and developmental harm.  This is particularly of concern for babies and children.”

In 2016 the FDA issued a final rule banning 19 antimicrobials from consumer antiseptic washes, concluding they were neither safe nor effective. The agency said there was no data to “demonstrate that there is any additional benefit from the use of these active ingredients in consumer antiseptic wash products compared to nonantibacterial soap and water.” However, due to industry pressure, the FDA delayed their decision on benzalkonium chloride, benzethonium chloride, and chloroxylenol. The FDA then extended the 2016 deferral several more times and has still not reached a decision.  

“The FDA’s ruling on these chemicals is eight years overdue,” said Eve Gartner, Director of Crosscutting Toxics Strategies at Earthjustice. “The agency’s foot-dragging has enabled the use of these ingredients in hand soaps to skyrocket, despite manufacturers’ failure to present evidence of their safety or utility. It’s past time for the FDA to act to stop the harm.”

 

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